Adverse Event Reporting


MasterControl provides GxP process management software solutions to help regulated FDA companies comply with adverse event reporting regulation.

Adverse event reporting is based on ICH, FDA and other regulatory standards. Conforming to requirements established by GCP for adverse event reporting is much simpler when document control and process technology enablers are implemented in GCP environments.

The MasterControl suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, including safeguarding of adverse event reporting processes. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better GxP process management.

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Comply with FDA Adverse Event Reporting Regulation

As part of the FDA’s adverse event reporting regulation, all manufacturers must send adverse drug reaction reports voluntarily. The FDA also requires that health care professionals and consumers send reports voluntarily through the MedWatch program. Clinical reviewers in the Center for Drug Evaluation Research (CDER) and the Center for Biologics Evaluation and Research (CBER) then evaluate all of these reports to detect safety signals and to monitor drug safety.

The entire adverse event reporting process can seem like a daunting task when manufacturers also must comply with other industry GxP best practices. MasterControl Customer Complaints™ is provides dynamic solutions to help regulated companies effectively and efficiently manage their adverse event reporting processes. MasterControl Customer Complaints features the following:

  • MedWatch Form—for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist while ensuring that all required data is immediately collected.
  • CAPA Integration—ensures that any serious quality problem is automatically escalated for faster resolution.
  • Analytics and Reporting—increases management oversight and demonstrates appropriate controls to regulatory agencies.
  • Simple Three-Step Process—automatically moves a pre-configured form throughout the customer complaint process to ensure a satisfactory resolution of the issue.
  • Compliant System—ensures regulatory compliance with FDA regulations, including 21 CFR Part 11.

How MasterControl Facilitates the Process of Adverse Event Reporting

MasterControl, the foremost developer of quality audit, document control and process management solutions, provides the technology that enables GCP regulated companies and organizations to streamline all of their processes, including adverse event reporting.

MasterControl's system for adverse event reporting is comprehensive and fully documented because all of the processes in the entire quality management system are interconnected to assure regulatory compliance.

Learn More About Adverse Event Reporting

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To learn more about how MasterControl GxP process management software can help regulated companies streamline adverse event reporting, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.